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What is EVZIO? (naloxone auto-injector)

EVZIO is a prescription medicine used in adults and children for the treatment of an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond.

EVZIO is to be given right away and does not take the place of emergency medical care. Get emergency medical help right away after the first dose of EVZIO, even if the person wakes up.

EVZIO is safe and effective in children for known or suspected opioid overdose.

https://www.evzio.com/patient/

Evzio (naloxone auto-injector) Approved to Reverse Opioid Overdose

FDA approved Evzio (naloxone hydrochloride injection), a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector.

Evzio is the first auto-injector designed to deliver a dose of naloxone outside of a health care setting. (FDA, USA, 2014)

http://wayback.archive-it.org/7993/20161022205011/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391465.htm

From Peers to Lay Bystanders: Findings from a Decade of Naloxone Distribution in Pittsburgh, PA.

Bennett AS, Bell A, Doe-Simkins M, Elliott L, Pouget E, Davis C.

J Psychoactive Drugs. 2018 Feb 9:1-7. doi: 10.1080/02791072.2018.1430409.

https://www.ncbi.nlm.nih.gov/pubmed/29424656

Biotech: The next naloxone? Companies, academics search for better overdose-reversal drugs

ATLANTA — Dr. Nora Volkow has heard a frightening scenario play out around the country. People are administering naloxone to synthetic opioid drug users who have overdosed. But the antidote doesn’t work well. So they give another dose. And it’s only after multiple doses — four, five, even six times — that drug users finally come to their senses.

Naloxone is the only widely available drug to reverse opioid overdoses. But anecdotal reports of its limitations against synthetic opioids are on the rise. Spurred by that public health threat — as well as a booming commercial market for the antidote — drug companies, researchers, and health officials are eagerly eyeing the development of new treatments to augment the use of naloxone or, in some cases, potentially replace it. (statnews.com, USA, 10.04.2018)

https://www.statnews.com/2018/04/10/next-naloxone-overdose-reversal-drugs/

Impacts of an opioid overdose prevention intervention delivered subsequent to acute care.

Banta-Green CJ, Coffin PO, Merrill JO, Sears JM, Dunn C, Floyd AS, Whiteside LK, Yanez ND, Donovan DM.

Inj Prev. 2018 Feb 7. pii: injuryprev-2017-042676. doi: 10.1136/injuryprev-2017-042676.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29436397

Management of Suspected Opioid Overdose With Naloxone by Emergency Medical Services Personnel [Internet].

Chou R, Korthuis PT, McCarty D, Coffin P, Griffin J, Davis-O’Reilly C, Grusing S, Daya M.

Rockville (MD): Agency for Healthcare Research and Quality (US); 2017 Nov.

https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0098626/

One-on-one care management and procurement of Naloxone for ambulatory use.

Whittington R, Whittington K, Whittington J, Porter J, Zimmermann K, Case H, Berg S.

J Public Health (Oxf). 2018 Feb 16. doi: 10.1093/pubmed/fdy029.

https://www.ncbi.nlm.nih.gov/pubmed/29462351

Effects of naloxone distribution to likely bystanders: Results of an agent-based model.

Keane C, Egan JE, Hawk M.

Int J Drug Policy. 2018 Mar 7;55:61-69. doi: 10.1016/j.drugpo.2018.02.008.

http://www.ijdp.org/article/S0955-3959(18)30043-4/fulltext

Does training people to administer take-home naloxone increase their knowledge? Evidence from Australian programs.

Dietze PM, Draper B, Olsen A, Chronister KJ, van Beek I, Lintzeris N, Dwyer R, Nelson M, Lenton S.

Drug Alcohol Rev. 2018 Feb 22. doi: 10.1111/dar.12680.

Abstract

https://www.ncbi.nlm.nih.gov/pubmed/29473245

Increasing Naloxone Awareness and UseThe Role of Health Care Practitioners.

Adams JM. 

JAMA. Published online April 05, 2018. doi:10.1001/jama.2018.4867

https://jamanetwork.com/journals/jama/fullarticle/2678206

Opioid Overdose Education for Individuals Prescribed Opioids for Pain Management: Randomized Comparison of Two Computer-Based Interventions.

Huhn AS, Garcia-Romeu AP, Dunn KE.

Front Psychiatry. 2018 Feb 12;9:34. doi: 10.3389/fpsyt.2018.00034.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5816336/

USA. Surgeon General’s Advisory on Naloxone and Opioid Overdose

I, Surgeon General of the United States Public Health Service, VADM Jerome Adams, am emphasizing the importance of the overdose-reversing drug naloxone. For patients currently taking high doses of opioids as prescribed for pain, individuals misusing prescription opioids, individuals using illicit opioids such as heroin or fentanyl, health care practitioners, family and friends of people who have an opioid use disorder, and community members who come into contact with people at risk for opioid overdose, knowing how to use naloxone and keeping it within reach can save a life.

BE PREPARED. GET NALOXONE. SAVE A LIFE. (surgeongeneral.gov, 05.04.2018)

https://www.surgeongeneral.gov/priorities/opioid-overdose-prevention/naloxone-advisory.html

Naloxone.

Jordan MR, Morrisonponce D.

StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2017 Jun-. 2017 Oct 10.

https://www.ncbi.nlm.nih.gov/books/NBK441910/

Nyxoid – Naloxon (Nasalspray)

Dies ist eine Zusammenfassung des Europäischen Öffentlichen Beurteilungsberichts (EPAR) für Nyxoid.

Hierin wird erläutert, wie die Agentur das Arzneimittel beurteilt hat, um zu ihren Empfehlungen für die Zulassung des Arzneimittels in der EU und die Anwendungsbedingungen zu gelangen. Diese Zusammenfassung ist nicht als praktischer Rat zur Anwendung von Nyxoid zu verstehen.

Wenn Sie als Patient praktische Informationen über Nyxoid benötigen, lesen Sie bitte die

Packungsbeilage oder wenden Sie sich an Ihren Arzt oder Apotheker. (EMA – European Medicines Agency, EMA/626193/2017, EMEA/H/C/004325, Zusammenfassung des EPAR für die Öffentlichkeit, 12.12.2017)

http://www.ema.europa.eu/docs/de_DE/document_library/EPAR_-_Summary_for_the_public/human/004325/WC500240208.pdf

International patent applications for non-injectable naloxone for opioid overdose reversal: Exploratory search and retrieve analysis of the PatentScope database.

McDonald, R., Danielsson Glende, Ø., Dale, O. and Strang, J. (2018)

Drug and Alcohol Review, 37: 205–215. doi:10.1111/dar.12571

Abstract

http://onlinelibrary.wiley.com/doi/10.1111/dar.12571/full

SMMGP FreeLearn: Naloxone Saves Lives

SMMGP - Substance Misuse Management in General Practice, 2018 (Registrierung erforderlich)

https://www.smmgp-elearning.org.uk/course/index.php?categoryid=2

USA. Americans Need Naloxone and Pharmacists Shouldn’t Hesitate to Give It to Them

Every generation struggles with their own set of public health issues. Our generation is faced with the opioid epidemic–which has been brewing for over 20 years. A closer look into the past few decades reveal a staggering trend: levels of prescription opioid use grew exponentially from 1999 to 2014, although there was no overall change in the amount of pain that Americans reported. In light of unprecedented overdose rates, President Trump has declared the issue a public health emergency.

For reducing overdose deaths, widespread distribution of naloxone–an overdose medication used to block or reverse the effects of opioid drugs–remains the primary measure that can help immediately. Moreover, nearly every state has modified relevant laws and regulations to encourage standing orders for naloxone. Through these standing orders, states have essentially designated a prescription for naloxone to all of their citizens.

This means that pharmacists are now clear stakeholders. They have the clinical responsibility to dispense this life-saving drug and provide patient education about its use. However, widespread distribution of naloxone has been hampered by pharmacists’ misconceptions about criminal liability. (IRETA, 07.02.2018)

http://ireta.org/2018/02/07/americans-need-naloxone-and-pharmacists-shouldnt-hesitate-to-give-it-to-them/

A Highly Publicised Research Paper on Naloxone is Spreading Dangerous Misinformation

A new research paper on the life-saving medication naloxone, which reverses opioid overdoses, is spreading dangerous misinformation that could cost lives.

The paper is entitled The Moral Hazard of Lifesaving Innovations: Naloxone Access, Opioid Abuse, and Crime, and is authored by two US researchers: Jennifer L. Doleac and Anita Mukherjee. The paper claims that access to naloxone – one of the WHO’s essential medicines – encourages “riskier behaviours with respect to opioid abuse”, increases “opioid-related theft”, and does not reduce opioid-related deaths.

The paper has not been peer-reviewed, yet its findings have been widely cited in the press – including by the Washington Post and CNN. Though less than two weeks have passed since its publication, this paper has the potential to have profound effects on public policy; it is ammunition for the countless policymakers and press pundits who would rather perpetuate the failure of prohibition than introduce policies that reduce harm. (Talking Drugs, UK, 19.03.2018)

https://www.talkingdrugs.org/naloxone-paper-spreads-misinformation

Pharmacokinetics of concentrated naloxone nasal spray for opioid overdose reversal: Phase I healthy volunteer study.

McDonald, R., Lorch, U., Woodward, J., Bosse, B., Dooner, H., Mundin, G., Smith, K., and Strang, J. (2018)

Addiction, 113: 484493. doi: 10.1111/add.14033.

http://onlinelibrary.wiley.com/doi/10.1111/add.14033/full

The Moral Hazard of Lifesaving Innovations: Naloxone Access, Opioid Abuse, and Crime

Doleac, Jennifer L. and Mukherjee, Anita, (March 6, 2018). Available at SSRN:

https://ssrn.com/abstract=3135264

Featured News: Naloxone Administration May Lead to Complications

There seem to be a growing number of cases of high amounts of fluid in the lungs – known as noncardiogenic pulmonary edema – following administration of the opioid overdose antidote naloxone, experts said at a recent meeting of the New York Society of Addiction Medicine annual meeting.

“The cause of naloxone-associated pulmonary edema is unclear. It may be that it is part of the natural history of opioid overdose, and we are just seeing it more often because we have the ability to save patients using an antidote. It could also be because when we wake people with naloxone, they try to take a deep breath against a closed airway, causing barotraumas – injuries caused by increased air or water pressure,” says Nicholas Nacca, MD, Assistant Professor of Emergency Medicine and Medical Toxicologist at the University of Rochester Medical Center. (Partnership for Drug-Free Kids, 08.02.2018)

https://drugfree.org/learn/drug-and-alcohol-news/featured-news-naloxone-administration-may-lead-complications

USA. The ‘moral hazard’ of naloxone in the opioid crisis

(...) As opioid usage has worsened in the United States, more and more jurisdictions have acted to increase access to naloxone. Not only first responders but also friends, family and even librarians have started to administer it. These state laws were passed at different times, giving researchers Jennifer Doleac and Anita Mukherjee a sort of a natural experiment: They could look at what happened to overdoses in areas that liberalized naloxone access and compare the trends there to places that hadn’t changed their laws. 

Their results are grim, to say the least: “We find that broadening Naloxone access led to more opioid-related emergency room visits and more opioid-related theft, with no reduction in opioid-related mortality.” (Washington Post, Opinion, 08.03.2018)

https://www.washingtonpost.com/opinions/the-moral-hazard-of-naloxone-in-the-opioid-crisis/2018/03/08/c3584f16-2259-11e8-86f6-54bfff693d2b_story.html